BORTESAM Injection 2ml

Introduction About BORTESAM INJECTION

BORTESAM INJECTION contains Bortezomib, which belongs to the group of medicines
called Antineoplastic agents. It is used in adult patients alone or with
pegylated liposomal doxorubicin/dexamethasone to manage progressive multiple
myeloma when anticancer therapy or hematopoietic stem cell transplantation
becomes unsuitable to manage the disease.

BORTESAM INJECTION is also used in adult patients with rituximab,
cyclophosphamide, doxorubicin, and prednisone to manage unmanageed mantle cell
lymphoma when hematopoietic stem cell transplantation becomes unsuitable to
manage the disease.

Multiple myeloma is a type of cancer that occurs in plasma cells (white blood
cells) and is generally characterized by symptoms such as bone pain, nausea,
constipation, and loss of appetite. Mantle Cell Lymphoma is a rare form of
cancer that affects the lymphatic system and is generally characterized by
symptoms such as loss of appetite, fever, nausea, and/or vomiting.

Your doctor may advise you to do regular blood tests to check your blood counts
before and during management with BORTESAM INJECTION. It is not recommended for
use in patients with severe lung or heart disease.

Before receiving BORTESAM INJECTION, inform your doctor if you have bleeding
problems, diarrhea, constipation, nausea or vomiting, shortness of breath or
cough, seizures, congestive heart failure, mild or moderate renal impairment,
and/or moderate or severe liver impairment.

BORTESAM INJECTION is not recommended for use by pregnant and breastfeeding
women. BORTESAM INJECTION is also not indicated for use in children and
adolescents (below 18 years of age).

The most common side effects of receiving BORTESAM INJECTION are dizziness,
increased heartbeat, sweating, abnormal vision, paresthesia (burning or pickling
sensation), muscle pain, and headache. Inform your doctor if any of the symptoms
worsen during or after management with BORTESAM INJECTION.

Uses Of BORTESAM INJECTION

Used in adults:

• To manage progressive multiple myeloma when anticancer therapy or hematopoietic stem cell transplantation becomes unsuitable to manage the disease (alone or in combination with pegylated liposomal doxorubicin/dexamethasone)
• To manage unmanageed mantle cell lymphoma (with rituximab, cyclophosphamide, doxorubicin, and prednisone when hematopoietic stem cell transplantation becomes unsuitable to manage the disease)

How BORTESAM INJECTION Works

BORTESAM INJECTION works by inhibiting proteasomes (enzymes responsible for
breaking down proteins into smaller compounds for cells), which leads to
imbalance in the cancer cell, thus resulting in its destruction and thereby
managing multiple myeloma and mantle cell lymphoma in affected individuals.

How to use BORTESAM INJECTION

BORTESAM INJECTION will be given to you only by a doctor or a nurse into a vein
as an intravenous infusion or into the skin as a subcutaneous injection. Your
doctor will decide the correct dose and duration of BORTESAM INJECTION for you
depending upon your age, body weight, and disease condition.

Side Effects Of BORTESAM INJECTION

Common

• fluid retention
• difficulty or problems sleeping
• altered level of consciousness, confusion
• dizziness, abnormal vision
• chest discomfort and sweating
• cough, hiccups
• ringing in the ears, ear discomfort
• difficulty swallowing
• infection or inflammation of the stomach and intestine
• throat pain, decreased appetite
• infection of the urinary tract
• pain in limbs, numbness, fever
• burning or pickling sensation
• nausea or vomiting
• constipation with or without bloating (can be severe)
• diarrhea
• tiredness, weakness
• muscle or bone pain
• low or high blood pressure
• sudden fall of blood pressure while standing, which may lead to fainting
• headache
• general ill feeling, pain
• vertigo (spinning sensation), light-headedness
• shivering
• chest pain or shortness of breath with exercise
• itching of the skin
• lumps on the skin or dry skin
• facial blushing or tiny broken capillaries
• redness of the skin
• dehydration
• heartburn, bloating, belching, wind, stomach pain, bleeding from your bowels or stomach
• sore mouth or lip, dry mouth, mouth ulcers
• weight loss
• loss of taste
• muscle cramps, muscle spasms, muscle weakness, and pain in your limbs
• blurred vision
• nose bleeds
• hair loss and abnormal hair texture

Uncommon

• inflammation of a vein and blood clots in your veins and lungs
• problems with blood clotting
• insufficient circulation
• inflammation of the lining around your heart or fluid around your heart
• bloody stools or bleeding from mucosal membranes such as the mouth or vagina
• cerebrovascular disorders
• speech disorders
• memory impairment or loss
• hearing loss, deafness or ringing in the ears, ear discomfort
• hormone abnormality that may affect salt and water absor
• overactive thyroid gland
• swelling of your lymph glands
• joint or muscle stiffness, sense of heaviness, pain in your groin
• redness or pain at the injection site
• mouth pain
• skin or tooth infection
• genital pain, problem having an erection
• weight increase, thirst
• hepatitis, sepsis
• skin reactions and disorders (which may be severe and life-threatening), skin ulcers
• bruises, falls, and injuries

Rare

• serious nerve inflammation, which may cause paralysis and difficulty breathing
• flushing
• discoloration of the veins
• inflammation of the spinal nerve
• ear problems such as bleeding from the ear
• underactivity of the thyroid gland
• abnormal bowel function
• signs of bleeding in the brain, such as headache and confusion
• yellow discoloration of the eyes and skin (jaundice)
• breast disorders
• vaginal tears
• loss of body mass, fistula
• joint effusion, fracture
• kidney cancer
• skin conditions such as psoriasis (itching) and skin cancer
• abnormal reaction to blood transfusions
• partial or total loss of vision, drooling
• decreased sex drive
• bulging eyes
• hernia, gallstones, rectal pain
• brittle/weak nails
• intestinal ulcers
• multi-organ failure

Stop receiving BORTESAM INJECTION and contact your doctor immediately if you
experience any of the following side effects:

• meningitis, Epstein-Barr virus infection, genital herpes
• tonsillitis, mastoiditis
• post-viral fatigue syndrome
• grade 4 neuropathy (life-threatening damage or dysfunction of one or more nerves) and/or severe autonomic neuropathy (nerve damage that controls automatic body functions)
• signs of progressive multifocal leukoencephalopathy (neurological disorder) such as clumsiness or loss of coordination, difficulty walking, and facial drooping
• signs of posterior reversible encephalopathy syndrome (a rare rapidly evolving neurological disorder) such as seizure, hypertension, headache, lethargy, confusion, blindness
• signs of peripheral neuropathy (nerve damage that occurs in hands and feet) such as gradual onset of numbness, prickling or tingling in feet or hands, sharp, jabbing, throbbing, or burning pain, and extreme sensitivity to touch
• cardiac failure
• signs of tumor lysis syndrome (a condition that occurs when tumor cells release their contents into the bloodstream), such as nausea with or without vomiting, lack of appetite, weakness, and dark urine
• signs of pulmonary hypertension (type of high blood pressure that affects arteries in the lungs and in the heart) such as blue lips and skin, chest pressure or pain, and dizziness
• acute diffuse infiltrative pulmonary disorders (group of lung disorders) such as shortness of breath, coughing (typically nonproductive), decreased exercise tolerance, and weakness
• signs of Guillain-Barre syndrome (serious nerve inflammation) such as paralysis and difficulty breathing
• signs of allergy, such as a serum-sickness-type reaction
• signs of polyarthritis (a type of joint disease that involves at least five joints) such as pain, stiffness, swelling or redness in the affected area, or rash
• signs of auto-immune disorders such as proliferative glomerulonephritis

How To Manage Side Effects

!### Constipation

Eat more fiber-rich foods, especially soluble fibers. Keep yourself hydrated.
Inform your doctor if the symptoms do not improve.

!### Diarrhea

Drink a lot of fluids, such as water or fruit juices, to keep yourself hydrated.
Inform your doctor if the symptoms do not improve.

Headache

Rest and relax. Drink plenty of fluids, such as water or electrolytes. Apply a
pain-relieving balm to the head if required. Do not consume alcohol. Inform your
doctor if the symptoms do not improve.

!### Nausea And Vomiting

Stick to simple meals. Avoid eating oil-rich or spicy foods. Inform your doctor
if the symptoms do not improve.

!### Stomach Pain

Try to rest and relax. Eat and drink slowly or try to have smaller and more
frequent meals. Keep a heat pad on your stomach. If the symptoms do not improve,
contact your doctor.

Warning & Precautions

!### Pregnancy

Consult your doctorBORTESAM INJECTION is not recommended for use during pregnancy or by women
planning for pregnancy. It should be used with caution in women with
childbearing potential who should use effective contrace
receiving BORTESAM INJECTION.

!### Breastfeeding

ContraindicatedBORTESAM INJECTION is not recommended for use by breastfeeding women. Consult
your doctor before receiving BORTESAM INJECTION.

!### Driving and Using Machines

Use with CautionDo not drive or operate any machines if you feel dizzy, tired, syncope
(fainting), and/or blurred vision after receiving BORTESAM INJECTION.

!### Kidney

Use with CautionBORTESAM INJECTION should be used with caution in patients with kidney problems
such as mild to moderate renal impairment. Consult your doctor before receiving
BORTESAM INJECTION.

!### Liver

Use with CautionBORTESAM INJECTION should be used with caution in patients with moderate or
severe liver problems, such as hepatic impairment. Consult your doctor before
receiving BORTESAM INJECTION.

!### Allergy

ContraindicatedDo not receive BORTESAM INJECTION if you are allergic to bortezomib, boron, or
any other ingredients of this medicine. Consult your doctor before receiving
BORTESAM INJECTION.

!### Lungs

Consult your doctorBORTESAM INJECTION is not recommended for use in patients with severe lung
problems. It should be used with caution in patients with hepatitis B virus
disease. Consult your doctor before receiving BORTESAM INJECTION.

!### Heart Disease

Consult your doctorBORTESAM INJECTION is not recommended for use if you have severe heart problems.
BORTESAM INJECTION should be used with caution in patients suffering from heart
problems such as congestive heart failure. Consult your doctor before receiving
BORTESAM INJECTION.

!### Use In Pediatrics

ContraindicatedBORTESAM INJECTION is generally not recommended for use in children and
adolescents (aged below 18 years). Consult your child’s doctor for advice before
administering BORTESAM INJECTION to your child.

!### Use In Geriatrics

Use with CautionBORTESAM INJECTION should be used with caution in elderly patients (aged 65
years and above). Consult your doctor before receiving BORTESAM INJECTION.

Others

Before receiving BORTESAM INJECTION, inform your doctor if you have:

• low red or white blood cell count
• bleeding problems and/or a low number of platelets in your blood
• diarrhea, constipation, nausea, or vomiting
• fainting, dizziness, or light-headedness in the past
• numbness, tingling, or pain in the hands or feet (neuropathy) in the past
• blood pressure problems
• shortness of breath or cough
• seizures
• shingles (a viral infection that causes swelling around the eyes or spreads across the body)
• symptoms of tumor lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances, and shortness of breath
• signs of a serious brain infection such as memory loss, trouble thinking, difficulty walking, or loss of vision
• muscle cramping, muscle weakness
• confusion, visual loss or disturbances, blindness, seizures, headaches
• shortness of breath, swelling of your feet or changes in your heartbeat, high blood pressure, tiredness, or fainting
• coughing and breathing difficulties or tightness in the chest

Interactions

A. Drug-Drug interactions:

Before taking BORTESAM INJECTION, inform your doctor if you are taking any of
the following medicines:

• ketoconazole (used to manage fungal infections)
• omeprazole (used to manage indigestion and heartburn)
• dexamethasone (used to manage inflammation and severe allergies)
• melphalan, prednisone (used to manage multiple myeloma)
• ritonavir (used to manage HIV infection)
• rifampicin (an antibiotic used to manage bacterial infections)
• carbamazepine, phenytoin, or phenobarbital (used to manage epilepsy)
• St. John’s wort (herbal medicine used to manage depression)
• oral antidiabetics (used to manage diabetes) Ex. metformin, glimepiride
• adalimumab (used to manage pain and swelling due to arthritis)
• lomitapide (used to manage cholesterol levels)

Overdosage:

BORTESAM INJECTION will be administered to you only by a doctor or a nurse in a
hospital, and so you are unlikely to receive an overdose. However, consult your
doctor if you experience any unusual symptoms of BORTESAM INJECTION, such as the
acute onset of symptomatic hypotension (low blood pressure while standing up
from a lying position) and thrombocytopenia (a condition marked by a low
platelet count).

Synopsis

Drug	:	Bortezomib
Pharmacological Category	:	Anti-neoplastic agent
Therapeutic Indication	:	Multiple myeloma, Mantle cell Lymphoma
Dosage Forms	:	Injection

More Information

• Store BORTESAM INJECTION in a refrigerator at 2-8°C

FAQs About BORTESAM INJECTION

Q: How is BORTESAM INJECTION administered?

A: BORTESAM INJECTION will be given to you only by a doctor or a nurse into a
vein as an intravenous infusion or into the skin as a subcutaneous injection.
Your doctor will decide the correct dose and duration of BORTESAM INJECTION for
you depending upon your age, body weight, and disease condition.

Q: Can BORTESAM INJECTION be used during pregnancy?

A: BORTESAM INJECTION is not recommended for use during pregnancy or by women
planning for pregnancy. It should be used with caution in women with
childbearing potential who should use effective contrace
receiving BORTESAM INJECTION.

Q: Who should avoid receiving BORTESAM INJECTION?

A: BORTESAM INJECTION is not recommended for use in patients with severe lung
and liver problems, and it is also not recommended for use in pregnant and
breastfeeding women. BORTESAM INJECTION is also not indicated for use in
children and adolescents (below 18 years of age). Consult your doctor before
receiving BORTESAM INJECTION.

Q: Can I drive after receiving BORTESAM INJECTION?

A: Do not drive after receiving BORTESAM INJECTION since it may cause dizziness,
tiredness, syncope (fainting), and/or blurred vision, which may affect your
ability or concentration to drive. Consult your doctor before receiving BORTESAM
INJECTION.

Q: Can BORTESAM INJECTION be used in patients with liver problems?

A: BORTESAM INJECTION should be used with caution in patients with moderate or
severe liver problems, such as hepatic impairment. Consult your doctor before
receiving BORTESAM INJECTION.

Useful Diagnostic Tests

• Albumin/Globulin Ratio, Serum
• Complete Blood Count
• Kidney Function Test